NCT00878202终止4 期
Impact of Clinical Follow-up and Therapeutic Education by Telemedicine in Chronic Heart Failure: a Randomized Multicenter Study.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Number of hospitalization days for heart failure
研究概览
简要总结
The purpose of the SEDIC study is to test a home based heart failure patient clinical follow-up and therapeutic education using telemedicine. This educational follow-up is based on an interactive information system (SCAD) including a touch screen personal computer for heart failure patient at home. An interactive algorithm has been developed to allow a self management teaching to the patient.Furthermore, a specialized nurse provide a clinical data follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 65 years old hospitalized for acute heart failure
- •Left ventricle systolic Dysfunction with ejection fraction < 45 %, documented in the previous 6 months
- •And at least one of the following criteria:
- •BNP before discharge from hospital > 350 pg/ml / EF < 35 % / Hospitalization for acute heart failure informed in the previous 6 months
排除标准
- •NYHA 4 at hospital discharge
- •Planned cardiac surgery or coronary revascularization
- •Hospitalization for ST-elevation acute coronary syndrome
- •Depressive syndrome with score > 20 at geriatric depression scale
- •Therapeutic education impossible
- •Technical problems with the device
- •Limited autonomy for device use
- •Patient not living in Basse-Normandie
- •Ongoing participation in another clinical trial
结局指标
主要结局
Number of hospitalization days for heart failure
时间窗: 12 months
次要结局
- Cardiovascular mortality(12 months)
- Total mortality(12 months)
- Rate of hospitalization for heart failure(12 months)
- Median of time up to mortality or hospitalization for heart failure(12 months)
- Number of medical consultation(12 months)
- Pharmaco-economic analysis(12 months)
- Disease knowledge questionnaire(12 months)
- Quality of life questionnaire ( Minnesota)(12 months)
- BNP(12 months)
- Six minutes walk test(12 months)
研究者
研究点 (9)
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